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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064097

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NDA 064097 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Alvogen Inc, Amneal Pharms Co, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Pharmachemie Bv, Pharmacia And Upjohn, Sagent Pharms, Sandoz Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Dr Reddys Labs Ltd, and Sun Pharma Global, and is included in twenty NDAs. It is available from twelve suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 064097

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 064097

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 064097

Suppliers and Packaging for NDA: 064097

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 064097 ANDA West-Ward Pharmaceuticals Corp 0143-9546 0143-9546-01 1 VIAL, MULTI-DOSE in 1 BOX (0143-9546-01) > 100 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Sep 13, 1994TE:APRLD:No


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